Safety evaluation of the food enzyme cyclomaltodextrin glucanotransferase from the non-genetically modified Anoxybacillus caldiproteolyticus strain TCM3-539

The food enzyme cyclomaltodextrin glucanotransferase ((1-4)-alpha-d-glucan:(1-4)-alpha-d-glucan 4-alpha-d-[(1-4)-alpha-d-glucano]-transferase; EC 2.4.1.19) is produced with the non-genetically modified bacteria Anoxybacillus caldiproteolyticus strain TCM3-539 by Hayashibara Co., Ltd. It is free from viable cells of the production strain. The food enzyme is intended to be used for the manufacture of glucosyl hesperidin and ascorbic acid 2-glucoside. Since residual amounts of total organic solids are removed by filtration, adsorption, chromatography and crystallisation, dietary exposure estimation was considered not necessary. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and one match with a respiratory allergen was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that the food enzyme does not give rise to safety concerns under the intended conditions of use.

Automated summary

The food enzyme is produced by non-genetically modified bacteria and does not contain viable cells of the production strain. It is used for the production of glucosyl hesperidin and ascorbic acid 2-glucoside. Due to the removal of residual organic solids, dietary exposure assessment is not necessary. A similarity search found one match with a respiratory allergen, indicating a low likelihood of allergic reactions. Based on the data provided, the food enzyme is considered safe under the intended conditions of use.